Dynamic arm brace assemblies and methods of use

ABSTRACT

Dynamic arm brace assemblies and methods of use are provided herein. An example device includes a torso connection member securable to a torso of a patient, a forearm support member that couples with at least a forearm of an patient, the forearm support member couples with the torso connection member so as to fix an elbow of the patient proximate the torso, the forearm support member being pivotally coupled to the torso connection member to allow for an angle between the forearm support member and a coronal plane of the patient, and a dynamic tensioning assembly that externally rotates the forearm support member and selectively sets the angle so as to stretch a shoulder capsule (capsule and adjacent tissue(s)) affected with adhesive capsulitis, reducing the adhesive capsulitis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit and priority of U.S. ProvisionalApplication Ser. No. 62/394,548, filed on Sep. 14, 2016, which is herebyincorporated by reference herein in its entirety for all purposes,including all references and appendices cited therein.

FIELD OF INVENTION

The present disclosure relates generally to orthopedic braces and moreparticularly, but not by limitation to arm brace assemblies that causeexternal rotation of a forearm of an patient to position the shoulder inan adducted (or neutral) position for optimal healing and recovery frominjury or surgery. In some embodiments, the braces described hereinimprove mobility and reduce (stiffness, adhesions, loss ofrange-of-motion) or adhesive capsulitis in patients. The brace mayinclude a system with detachable grips or handles to facilitaterange-of-motion exercises with a formal and/or home exercise program.

SUMMARY

According to some embodiments, the present disclosure is directed to adevice, comprising: (a) a torso connection member securable to a torsoof the patient; (b) a forearm support member that couples with at leasta forearm of an patient, wherein the forearm support member couples withthe torso connection member so as to fix an elbow of the patientproximate the torso, the forearm support member being pivotally coupledto the torso connection member to allow for an angle between the forearmsupport member and a coronal plane of the patient; and (c) a dynamictensioning assembly that externally rotates the forearm support memberand selectively sets the angle so as to stretch a shoulder capsuleaffected with adhesive capsulitis so as to reduce the adhesivecapsulitis.

According to some embodiments, the present disclosure is directed to adevice comprising: (a) a forearm support member that secures to at leasta forearm of an patient; (b) a torso connection member that ispositioned and secure proximate an iliac crest of the patient; (c)wherein the forearm support member couples with the torso connectionmember in such a way that an elbow of the patient is proximate to atorso of the patient; and (d) wherein the forearm support member and acoronal plane of the patient can be placed approximately normal to oneanother using a dynamic tensioning assembly.

According to some embodiments, the present disclosure is directed todevice comprising a support member that secures to at least a forearm ofan patient and secures an elbow of the patient proximate a torso of thepatient, wherein the support member is disposed at an angle measured byreference to a coronal plane of the patient, the angle being selectivelyadjusted using a dynamic tensioning member that causes external rotationof the forearm in order to stretch a shoulder capsule (shoulder capsule,joint, or soft-tissue) of a shoulder associated with the forearm.

According to some embodiments, the present disclosure is directed todevice comprising (a) an arm brace comprising: (i) an elbow and upperarm retaining portion; (ii) a forearm retaining portion; (iii) an anchorlocation on an outside surface of the forearm retaining portion; (iv) aretaining slot located on a rearward portion of the elbow and upper armretaining portion; and (v) an extendable, proximal grip disposed on aterminal end of the elbow and upper arm retaining portion, theextendable, proximal grip capable of sliding translation to adjust alength of the elbow and upper arm retaining portion, the extendable,proximal grip further comprising a pair of spaced apart hand grips; (b)a torso connection member comprising: (i) a body contoured to mate witha portion of a side of a torso of a patient at approximately an iliaccrest of the patient; and (ii) one or more securement members coupled tothe body, the one or more securement members configured to overlap anopposing side of the torso of the patient to secure the torso connectionmember on the torso; (c) a linkage that couples the elbow and upper armretaining portion with the torso connection member in such a way thatthe an elbow of the patient is next to the torso of the patient, whereinthe elbow and upper arm retaining portion is pivotally coupled with thelinkage; (d) a dial tensioner that is disposed on a forward portion ofthe body so as to be reachable by an opposing hand of the patient thatis not placed in the elbow and upper arm retaining portion; (e) aresilient strap that is coupled with the dial tensioner at one end, theresilient strap coupling with the forearm retaining portion using a clipthat releaseably connects with the anchor location, the resilient strapextending through the retaining slot; (f) wherein when the patientplaces their arm in the arm brace and rotates the dial tensioner, thearm brace pivots to externally rotate a forearm while the elbow ismaintained in a fixed position, resulting in stretching of a shouldercapsule of a shoulder of the patient, the resilient strap providing adynamic force that can be resisted against by the patient; and (g) ashoulder strap that overlaps a non-affected shoulder, the shoulder strapconnected on both its ends to the body of the torso connection member.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, together with the detailed description below, are incorporated inand form part of the specification, and serve to further illustrateembodiments of concepts that include the claimed disclosure, and explainvarious principles and advantages of those embodiments.

The methods and systems disclosed herein have been represented whereappropriate by conventional symbols in the drawings, showing only thosespecific details that are pertinent to understanding the embodiments ofthe present disclosure so as not to obscure the disclosure with detailsthat will be readily apparent to those of ordinary skill in the arthaving the benefit of the description herein.

FIG. 1A is a perspective view of an example device, constructed inaccordance with the present disclosure.

FIG. 1B illustrates both front elevation and side elevation views of thedevice of FIG. 1A on a patient.

FIG. 1C illustrates both a rear and side perspective views of the deviceof FIG. 1A.

FIG. 1D is a bottom perspective view of the example device of FIG. 1A.

FIG. 1E is a rear perspective view of a portion of the example device ofFIG. 1A.

FIG. 1F is a top down, partial view of the device of FIG. 1A showing aninitial position proximate a torso of a patient.

FIG. 1G is a top down, partial view of the device of FIG. 1A showing anexternally rotated forearm position of a patient.

FIG. 2A is a partial perspective view of another example device of thepresent disclosure comprising a gear-driven dynamic force assembly.

FIG. 2B is a partial perspective view of the gear-driven dynamic forceassembly.

FIGS. 2C and 2D collectively illustrate device movement between aninitial position (FIG. 2D) and an externally rotated position (FIG. 2C).

FIG. 3 is a top-down perspective view of another embodiment of a deviceof the present disclosure.

FIG. 4 includes both a top-down perspective view of another embodimentof a device of the present disclosure, as well as a front elevation viewthereof.

FIG. 5 is a top-down perspective view of another embodiment of a deviceof the present disclosure having a dynamic tensioning element in theform of a pre-tensioned hinge or torsion spring.

FIG. 6 is a top-down perspective view of another embodiment of a deviceof the present disclosure having a dynamic tensioning element in theform of a pre-tensioned hinge or torsion spring, in combination with atensioning strap.

FIGS. 7 and 8 collectively illustrate another example device of thepresent disclosure that comprises a compass-style dynamic tensioningelement.

FIG. 9 is a top-down perspective view of another embodiment of a deviceof the present disclosure, comprising a therapeutic handle for exercise.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

According to some embodiments, the present disclosure is directed to abrace device or apparatus that address a condition of adhesivecapsulitis, colloquially referred to as frozen shoulder (or anycondition or injury causing loss of mobility of the shoulder). Adhesivecapsulitis can result in a painful loss of range of motion. Bracesdescribed herein improve mobility range of motion to reduce pain andimprove shoulder functioning. Adhesive capsulitis and corresponding lossof external rotation of the arm is due to contracture of rotatorinterval tissue of the shoulder. While treating adhesive capsulitis hasbeen described, the device(s) of the present disclosure can be utilizedto effective treat any condition resulting in shoulder stiffness.

Patients can be referred to physical therapy or home treatment whenadhesive capsulitis or shoulder stiffness is diagnosed. Patients whofail to improve become surgical candidates.

The braces described herein can be used as an adjunct to typicalphysical therapy. In other embodiments it is envisioned that the bracescan be utilized in a stand-alone capacity.

The braces described herein can also be utilized in a post-surgicalsetting to maintain mobility. Indeed, post-surgery adhesive capsulitiswill begin to set in and re-tighten the shoulder unless intervention isinitiated soon after surgery.

Some applications for the devices of the present disclosure allow foruse as an adjunct in pre-operative settings in order to prepare anaffected shoulder for surgery (e.g., reduce adhesions and/or otherstiffness), and/or expedite post-operative recovery time.

Broadly, some embodiments described herein utilize dynamic stress toexternally rotate the forearm of the patient while simultaneouslymaintaining the elbow of the arm in close proximity to the torso.

In general, the braces described herein effect this reduction inadhesive capsulitis by providing a force or stress onto an arm of anpatient that causes external rotation of the arm (and specifically theforearm in some embodiments). Some embodiments incorporate means forproviding dynamic stress, such as selective or gradually increasing ofstress to stretch the shoulder as desired.

Some embodiments of braces described herein effectively places theforearm of a patient in an externally rotated position. This position isadvantageous when it is desired to place the shoulder of the patient inan adducted (or neutral) position. Placing the shoulder in an adductedposition is advantageous when the patient has suffered a shoulder injuryor is recovering from one or more types of shoulder surgery.

The devices of the present disclosure can be utilized to lengthen,stretch, rotate, and/or otherwise manipulate a shoulder capsule (capsuleand adjacent tissue(s)) in an affected shoulder connected to the forearmplaced in a device of the present disclosure. To be sure, the shouldercapsule, when affected by adhesive capsulitis, will undergo any ofthickening, fibrosis, and/or shrinkage due to inflammation and/or thedevelopment of adhesions. The devices of the present disclosurecounteract these deleterious effects by dynamic stretching andlengthening of the shoulder capsule by rotation of the humorous causedby external rotation of the forearm, while the elbow of the patient isheld in fixed position (distance) proximate the torso of the patient.

An example arm brace comprises a torso connection member, such as abelt, that is positioned on a torso of the patient. The torso connectionmember can be worn similarly to a belt and can be adjusted per thepatient. The brace device also comprises an arm support member thatcouples with at least a forearm of a patient. The arm support memberstabilizes the forearm of the patient.

In some embodiments the arm support member couples with the torsoconnection member in a pivoting manner to set an angle between the torsoconnection member and the arm support member, the angle being definedrelative to a coronal plane of the patient.

Some embodiments of the present disclosure comprise a dynamic tensioningassembly/means that position a forearm of a patient in an externallyrotated position. In some embodiments, the dynamic stressing meansplaces a greater magnitude of force to rotate the forearm initially, butthis force gradually decreases as the forearm moves into perpendicularrelationship with the coronal plane of the patient (or vice-versa inother embodiments based on the type of dynamic tensioning assemblyutilized).

FIGS. 1A-G illustrate an example dynamic brace device (referred toherein as “device 100”), constructed in accordance with the presentdisclosure. The device 100 comprises a torso member 102 (torsoconnection member), arm brace 104 (arm support member), and a dynamictensioning assembly 106. In some embodiments, the torso member 102 isconfigured to rest against a hip HP and/or lower portion of a patient'storso T, as illustrated on a patient P. A body of the the torso member102 is contoured to conform to the curvature of the torso T, around orproximate the iliac crest IC of the patient P. The body of the torsomember 102 matches the natural curvature of the patient's torso T thattypically provides a curvature above the iliac crest IC.

The torso member 102 provides a means of support for both the arm brace104. When the patient P places their forearm FA in the arm brace 104,the weight of the arm will rest against the patient's torso T throughthe torso member 102.

A location of the torso member 102 relative to the torso T results inalignment with a natural position of the elbow relative to the torsowhen the arm is in a relaxed position extended down the side of thetorso.

In one or more embodiments, the torso member 102 comprises one or moresecurement members 108 and 110. Additional or fewer securement memberscan be utilized. In various embodiments, the securement members 108 and110 are adjustable straps or belts that allow the device 100 to besecured around patients of varying size and shape.

A mechanical linkage 111 couples the torso member 102 and the arm brace104. In some embodiments, the mechanical linkage 111 comprises an upperarmature 112 and a lower armature 114. The arm brace 104 is pivotallycoupled to the upper armature 112 using a pivoting member 116. In someembodiments, the lower armature 114 can be removed. According to someembodiments, the arm brace 104 is pivotally coupled to the upperarmature 112 using any means that allows for pivoting such as a pin orshaft extending through a cylinder of the pivoting member 116.

In some embodiments, the upper armature 112 and lower armature 114 aresized to allow the elbow E of the patient P to be placed in closeproximity to the torso T of the patient P. Preferably, the elbow E ofthe patient P is located as close to the torso T, and the torso member102 as possible. Maintaining the elbow E in close proximity to the torsoT ensures that proper shoulder capsule SC movement is preserved duringexternal rotation of the forearm FA of the patient P.

In other embodiments, additional dynamic or pivoting force can beinduced when the pivoting member 116 comprises a torsion spring (orother torsion generating member) that can cause the arm brace 104 tointernally and/or or externally rotate, as desired. Aspects ofinternal/external rotation of the arm will be discussed in greaterdetail below, although in general, the dynamic tensioning assembly 106functions to cause the arm brace 104 to externally rotate and thepivoting member 116 can exert a torsion force that causes the arm brace104 to internally rotate. When used in combination, these opposingforces can allow the patient to exercise their shoulder capsule byexternally or internally rotating their forearm. When the patient isinternally rotating the forearm, the dynamic tensioning assembly 106resists the internal rotation, whereas when the patient is externallyrotating their forearm, the pivoting member 116 resists the externalrotation. These resistive forces for both internal and externalmovements allow the patient to exercise the shoulder capsule in twodifferent directions. If only the dynamic tensioning assembly 106 isutilized, external rotation of the forearm is not resisted, onlyinternal rotation, and vice versa if only the pivoting member 116 (suchas a torsion spring is utilized).

According to some embodiments, the arm brace 104 is a cradle thatreceives the arm of the patient P. The arm brace 104 comprises an elbowand upper arm retaining portion 118 and a forearm retaining portion 120.In some embodiments, the arm brace 104 comprises a proximal grip 122that can be gripped by a hand H of the patient P. In some embodiments, alength of the forearm retaining portion 120 can be increased ordecreased using an adjustment assembly 124. The adjustment assembly 124comprises a track 126 and locking nut 128 cooperate that that allow theproximal grip 122 to extend proximally or retract distally (towards theelbow E) to accommodate forearms of varying length. In operation, thelocking nut 128 is loosened allowing the proximal grip 122 to slidablytranslate along the track 126. When in a desired position, the lockingnut 128 can be tightened to secure the proximal grip 122 in position.

In general, the proximal grip is slidably extendable to selectively varya length of a forearm retaining portion of the forearm support member.

In some embodiments, the proximal grip 122 comprises a pair of griphandles 130 and 132 that are spaced apart from one another. Each of thegrip handles 130 and 132 can be used depending on an orientation of thedevice 100 (if being used on the right side or the left side of thetorso T). When the patient P is using the device 100 on their right arm,grip handle 130 is utilized. The opposite grip handle is used when thedevice 100 is arranged for left arm use.

Turning now to the dynamic tensioning assembly 106. In some embodiments,the dynamic tensioning assembly 106 comprises a dial tensioner 134, acable 136 in combination with the dial tensioner 134, and a dynamicforce member 138. In some embodiments, the dial tensioner 134 is mountedon capable of being mounted on the torso member 102 in a position thatis accessible to a hand of an opposing arm of the patient P that is notpositioned inside the arm brace 104. The cable 136 runs through the dialtensioner 134 and couples to a terminal end of the dynamic force member138.

The dynamic force member 138 extends around the elbow and upper armretaining portion 118 of the arm brace 104. In some embodiments, thedynamic force member 138 is inserted through a slot 140 fabricated intoan outer surface of the elbow and upper arm retaining portion 118 of thearm brace 104 to prevent the dynamic force member 138 from slippingunder the arm brace 104. An opposing terminal end of the dynamic forcemember 138 is provided with a clip 142 that cooperates with an anchor144 disposed along an outer surface of the forearm retaining portion 120of the arm brace 104. The clip 142 locks into the anchor 144.

In some embodiments, the dynamic force member 138 comprises anelastomeric cable or strap.

In operation, as the dial tensioner 134 is rotated, the cable 136 iscoiled within the dial tensioner 134, causing the cable 136 to pull onthe dynamic force member 138. Because the terminal end of the dynamicforce member 138 is anchored to an outer surface 150 of the forearmretaining portion 120 of the arm brace 104, as the dial tensioner 134 isturned, the dynamic force member 138 is stretched, causing the forearmretaining portion 120 of the arm brace 104 to pivot about the pivotingmember 116, causing the forearm retaining portion 120 of the arm brace104 to externally rotate.

In more detail, tensioning of the dynamic force member 138 creates aforce applied to the forearm retaining portion 120 of the arm brace 104that causes the stretching or other manipulation of the shoulder capsuleto reduce adhesive capsulitis in an affected shoulder.

With respect to the operation of the device 100 when being used by thepatient P. The patient P will first don the device 100 by locating thetorso member 102 appropriately on their torso T (near the iliac crestIC). Next, the patient will utilize the one or more straps 118/120 tosecure the device 100 onto the patient P. Once secured, the patient canplace their forearm FA into the arm brace 104. It will be understoodthat the natural or initial position of the device 100 will place theforearm FA in proximity to, or near, the front of the torso T. Thisplaces the device 100 in an acute angle X1 relative to a coronal planeC_(P) of the torso T. To place dynamic tension on the forearm FA, thepatient will begin to turn the dial tensioner 134 on the torso member102, which causes the cable 136 to tension the dynamic force member 138.Pulling on the dynamic force member 138 will result in external rotation(as illustrated by the dotted line and arrow) of the forearm retainingportion 120 of the arm brace 104. As the dial tensioner 134 is turned,the force created by the dynamic tensioning assembly 106 will begin totranslate the forearm retaining portion 120 the arm brace 104, movingthe forearm retaining portion 120 of the arm brace 104 to a positionthat further away from the torso T and closer to an angle X2 that issubstantially perpendicular/orthogonal to the coronal plane C_(P) of thetorso T.

In embodiments where the dynamic force member 138 is an elastic orresilient member, the elastic or resilient nature of the dynamic forcemember 138 allows the patient P to push or pull their forearm FA toexercise their shoulder joint S, reducing and/or eliminating adhesivecapsulitis in the shoulder joint S. Ideally, the patient should seek toposition their arm closer to angle X2 (see FIGS. 1B and 1G), butlimitations on mobility can hamper this magnitude of movement. Thus, thepatient can incrementally change their forearm angle between X1 and X2(see FIGS. 1F and 1G) in various sessions or over a period of time usingthe device 100 to improve their range of motion and reduce adhesivecapsulitis. At any position, the patient can achieve benefits of pushingor pulling against a force created by the dynamic force member 138.

It will also be understood that the dynamic tensioning assembly 106creates a dynamic force that varies according to forearm angle. That is,when the forearm is located proximate angle X1, the force created by thedynamic tensioning assembly 106 are less than when the dynamictensioning assembly 106 is used to place the forearm proximate angle X2.In other words, the dynamic tensioning assembly 106 exerts anincrementally increasing amount of force as the dial tensioner 134 isturned and as the arm brace transitions from X1 to X2. Again, the device100 can be otherwise configured to create an incrementally decreasingrange of force when transitioning from X1 to X2, rather thanincrementally increasing

Advantageously, the device 100, in operation, lengthens a shouldercapsule in an affected shoulder connected to the forearm. To be sure,the shoulder capsule, when affected by adhesive capsulitis, will undergoany of thickening, fibrosis, and/or shrinkage due to inflammation and/orthe development of adhesions. The device 100 counteracts thesedeleterious effects by dynamic stretching and lengthening of theshoulder capsule by rotation of the humorous caused by external rotationof the forearm, while the elbow of the patient is held in fixed positionproximate the torso of the patient.

In yet another advantage, the tensioning of the strap (e.g., dynamicforce member 138) allows the patient to internally rotate or externallyrotate the forearm support member (arm brace 104) to exercise theshoulder capsule. The strap resists the internal or external rotation ofthe forearm support member by the patient, allowing the patient toexercise the shoulder capsule. In some instances, if these exercises areperformed pre-operatively, the patient may avoid surgery by reducing theadhesive capsulitis to such a degree that the shoulder capsule isrehabilitated.

In various embodiments, as illustrated in FIGS. 1B and 1C, the device100 can comprise a shoulder strap 160. The shoulder strap 160 overlapsthe non-affected shoulder (shoulder not connected to the arm placed inthe device 100) and bears a portion of the weight of the device 100. Theshoulder strap 160 can connect to the torso member 102.

In some embodiments, the device 100 comprises the arm brace 104comprising several components such as the elbow and upper arm retainingportion 118 and forearm retaining portion 120. An anchor 144 (anchorlocation) is located on an outside surface of the forearm retainingportion. The retaining slot 140 is located on a rearward portion of theelbow and upper arm retaining portion.

In some embodiments, an extendable, proximal grip 121 is disposed on aterminal end of the elbow and upper arm retaining portion 118, and theextendable, proximal grip 121 is capable of sliding translation toadjust a length of the elbow and upper arm retaining portion 118. Theextendable, proximal grip 121 further comprises a pair of spaced aparthand grips 130 and 132.

As noted above, the device 100 comprises the torso connection member 102(torso member), and the torso member 102 can comprise a body contouredto mate with a portion of a side of a torso T of the patient atapproximately an iliac crest IC of the patient P.

The n torso member 102 comprises one or more securement members (108 and110) coupled to the body of the torso member 102. The one or moresecurement members are each configured to overlap an opposing side ofthe torso of the patient to secure the torso connection member on thetorso.

In some embodiments the device 100 includes a linkage that couples theelbow and upper arm retaining portion with the torso connection memberin such a way that the elbow of the patient is next to the torso of thepatient. The elbow and upper arm retaining portion is pivotally coupledwith the linkage, as noted above. This can include a dynamic pivoting(such as a torsion spring) or a free rotating pivot.

A dial tensioner is disposed on a forward portion of the body so as tobe reachable by an opposing hand of the patient that is not placed inthe elbow and upper arm retaining portion.

In some embodiments, a resilient strap is coupled with the dialtensioner at one end, the resilient strap coupling with the forearmretaining portion using a clip that releaseably connects with the anchorlocation, the resilient strap extending through the retaining slot.

It will be understood that when the patient places their arm in the armbrace and rotates the dial tensioner, the arm brace pivots to externallyrotate a forearm while the elbow is maintained in a fixed position,resulting in stretching of a shoulder capsule of a shoulder of thepatient, the resilient strap providing a dynamic force that can beresisted against by the patient. In some embodiments, the device 100includes a shoulder strap that overlaps a non-affected shoulder, theshoulder strap connected on both its ends to the body of the torsoconnection member.

FIGS. 2A-D collectively illustrate another example dynamic brace device(referred to herein as “device 200”), constructed in accordance with thepresent disclosure. The device 200 is similar in construction to that ofthe device 100 of FIGS. 1A-G, with respect to the torso member 202 andthe arm brace 204, but rather than using a dynamic tensioning assemblythat comprises a dynamic force member, the device 200 comprises adynamic tensioning assembly 206 that comprises a series of belt or chaindriven components in order to induce pivoting rotation of the arm brace204 relative to the torso member 202.

The device of FIGS. 2A-D can include any of the securement strapsdisclosed relative to FIGS. 1A-G.

In some embodiments, the dynamic tensioning assembly 206 comprises agear assembly comprising a geared torsion spring 208 and a tensioningdial 210 that is mechanically coupled with the geared torsion spring208.

In general, wherein turning of the tensioning dial 210 causes theforearm support member (arm brace 204) to externally rotate as thegeared torsion spring 208 is loaded. In more detail, the geared torsionspring 208 comprises a keyed hub 212, a rim 214, and a plurality ofelastomeric spokes 217 that extend between the keyed hub 212 and the rim214.

The geared torsion spring 208 is mounted on a keyed shaft 216 thatextends from a linkage 218 associated with the torso member 202. In someembodiments, the keyed shaft 216 is fixed in position. The keyed hub 212of the geared torsion spring 208 slides over the keyed shaft 216.

The rim 214 comprises a plurality of teeth 220 that are disposed on theouter surface of the rim 214. Similarly, the tensioning dial 210comprises a toothed gear 222. In one or more embodiments, a tracked belt224 couples the rim 214 of the geared torsion spring 208 with thetoothed gear 222 of the tensioning dial 210. Thus, as the tensioningdial 210 is rotated, a corresponding rotation of the torsion spring 208occurs. Because the rim 214 and the keyed hub 212 of the geared torsionspring 208 are connected to one another via the plurality of elastomericspokes 217, and the keyed hub 212 is held in fixed position on the keyedshaft 216, torsion force begins to build in the plurality of elastomericspokes 217 as the tensioning dial 210 is rotated. This also causes thearm brace 204 to pivot at the linkage 218 and externally rotate.

In sum, the load applied to the geared torsion spring creates a forceapplied to the forearm support member (arm brace 204) that causes thestretching of the shoulder capsule.

If the patient desires to lock the arm brace 204 in its angled position,a locking member 226 can be engaged. The locking member 226 retains theforearm support member (arm brace 204) at a selected angle position andthe geared torsion spring 208 with a selected loading. The lockingmember 226 translates forwardly to engage with the toothed gear 222 ofthe tensioning dial 210, preventing the tensioning dial 210 fromrotational movement.

FIGS. 2C-D illustrate various positions of the device 200, where in FIG.2C the device 200 positions the arm brace 204 proximate the torso of thepatient, while the position of FIG. 2D illustrates the device 200 in aposition where the arm brace 204 is substantially perpendicular to thecoronal plane C_(P) of the patient.

FIG. 3 illustrates an example embodiment of a brace device 310constructed in accordance with the present disclosure. The brace device310 comprises generally a torso member 312, an arm sling 316, and adynamic tensioning assembly 318. A coronal plane C_(P) is illustratedfor reference.

The torso member 312 can comprise a belt or similar structure thatsecurely wraps a torso 320 at any position. The arm sling 316 cancomprise a sleeve type sling in one embodiment. In another embodimentthe arm sling 316 can comprise one or more straps such as strap 322 thatsecures to a forearm 324.

The dynamic tensioning assembly 318 comprises a pre-tensioned orresiliently biased member that couples with the torso member 312 and thearm sling 316. The shape of the dynamic tensioning assembly 318 isconfigured to retain an elbow 326 in close proximity to the torso 320.In some embodiments, the dynamic tensioning assembly 318 provides arotating force that causes external rotation of the forearm 324. In oneembodiment the dynamic tensioning assembly 318 places the forearm 324into a position that is substantially perpendicular to the coronal planeC_(P).

Advantageously, the patient can push against the dynamic tensioningassembly 318 to exercise the arm and associated shoulder to reduce thelikelihood that adhesive capsulitis will occur or reoccur in theshoulder. The dynamic tensioning of the dynamic tensioning assembly 318will force the forearm 324 into external rotation when the patient stopspushing against the dynamic tensioning assembly 318. The dynamictensioning assembly 318 can be manufactured from any desired materialsincluding, but not limited to plastics, polymers, metals, alloys,composite materials, natural materials such as wood, and other materialsthat can provide the aforementioned dynamic pre-tensioning featuresdescribed herein.

FIG. 4 illustrates an example embodiment of a brace device 400constructed in accordance with the present disclosure. The device 400generally comprises a torso member 402, an elbow securement member 404,an arm sling 406, and a dynamic tensioning assembly 408. A coronal planeC_(P) is illustrated for reference.

The torso member 402 can comprise a belt or similar structure thatsecurely wraps a torso 410 at any position, but in some embodiments inalignment with a natural position of the elbow relative to the torsowhen the arm is in a relaxed position extended down the side of thetorso. The elbow securement member 404 can comprise a strap or loop ofmaterial that cooperates with the belt to maintaining the elbow of thearm in close proximity to the torso. The elbow securement member 404 cancomprise any suitable means for maintaining the elbow of the arm inclose proximity to the torso.

The arm sling 406 is configured to receive and retain a forearm and/orother portions of an arm 412 of the patient.

The dynamic tensioning assembly 408 comprises a buckle or other receiver414 mounted onto the arm sling 406, and a tensioning strap 416. The armsling 406 is mounted onto a portion of the arm sling 406 that isproximate an outside surface of the arm sling 406.

The tensioning strap 416 is secured to the torso member 402 foranchoring at one end. A terminal end 418 of the tensioning strap 416 islooped around or through the receiver (such as a buckle) 414 and wrapsback around the rear side of the torso. As the patient pulls on theterminal end 418 of the tensioning strap 416 will exert a force thatexternally rotates the forearm of the patient while the elbow securementmember 404 simultaneously maintains the elbow of the arm in closeproximity to the torso. The external rotation places the arm into asubstantially perpendicular relationship to the coronal plane C_(P) insome embodiments. In other embodiments, the dynamic tensioning assembly408 places the arm at any desired angular position relative to thecoronal plane C_(P), which can include angles that are greater or lessthan perpendicular to the coronal plane C_(P).

The terminal end 418 is provided with hook and loop fasteners or anothersecurement means for allowing the terminal end 418 to securely contactthe torso member 402 to retain the terminal end 418 in a desiredposition to maintain external rotation forces on the forearm.

The torso member 402 can also comprise tensioning indicia 420 printed ona front portion thereof. The tensioning indicia 420 allow a user to setthe dynamic tension of the device 400 accurately for every use.

In some embodiments, the torso member 402 and elbow securement member404 function as a single unitary unit. The torso member 402 and elbowsecurement member 404 can be a single loop or belt, for example.

FIG. 5 is another embodiment of a brace device 500 constructed inaccordance with the present disclosure. The brace device 500 utilizes atensioned pivoting member 502, such as a pre-tensioned hinge or spring(such as a torsion spring) that externally rotates an arm brace 504 intoa desired position, such as substantially perpendicular to the coronalplane C_(P).

FIG. 6 illustrates another example embodiment of a brace device 600 thatincludes a tensioned pivoting member 602 and a tensioning strap 604 (aswell as a receiver or buckle similar to the embodiment of FIG. 4).

FIGS. 7 and 8 collectively illustrate another example embodiment of abrace device 700 that includes a compass type force member 702 thatprovides dynamic forces to externally rotate the forearm into positionrelative to the coronal plane C_(P).

FIG. 9 illustrates another example embodiment of a brace device 900 thatincludes an arm brace 902, an elbow positioning member 904, and adynamic tensioning member 906. The elbow positioning member 904 includesa belt 908 that wraps around a torso 910 and a loop or strap 912 thatwraps around an elbow 914. The belt 908 and loop or strap 912 arecoupled together in some embodiments.

In one embodiment the dynamic tensioning member 906 comprises asubstantially V-shaped member that exerts dynamic forces on the armbrace 902 to externally rotate the forearm of the patient. A portion 916of the dynamic tensioning member 906 contacts the torso 910 and aportion 918 of the dynamic tensioning member 906 contacts the arm brace902 (e.g., forearm). The patient can also compress the portion 916 andportion 918 towards one another. Resiliency of the dynamic tensioningmember 906 causes the portions 916 and 918 to spring back to a desiredexternally rotated forearm position when the patient is not exertingcompressive forces on the dynamic tensioning member 906. Again, thisdynamic tensioning member 906 can be constructed from materials thatallow the dynamic tensioning member 906 to exert a greater magnitude offorce to externally rotate the forearm when the portions 916 and 918 arecloser together (e.g., at an angle where the forearm is less thanperpendicular to the coronal plane), where this force decreases inmagnitude as the forearm is externally rotated closer to perpendicularwith the coronal plane.

An example detachable therapy handle is illustrated as 920. The therapyhandle can be coupled mechanically to the arm brace 902 or other portionof the brace device 900. The handle allows the patient to grip and exertforce against the dynamic tensioning member 906 to exercise the shoulderjoint of the shoulder associated with the arm in the brace device 900.

While aspects of the present disclosure have been disclosed for treatingan affected area of a patient, such as a shoulder affected with adhesivecapsulitis, the teachings of the present disclosure are not so limited.The present disclosure can be extended and adapted to treating otherconditions that are similar in nature to adhesive capsulitis, and thedevices disclosed herein can be adapted for use on other joints such asknees, wrists, elbows, ankles, and other similar structures.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the present invention. Thus, theappearances of the phrases “in one embodiment” or “in an embodiment” or“according to one embodiment” (or other phrases having similar import)at various places throughout this specification are not necessarily allreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Furthermore, depending on the context ofdiscussion herein, a singular term may include its plural forms and aplural term may include its singular form. Similarly, a hyphenated term(e.g., “on-demand”) may be occasionally interchangeably used with itsnon-hyphenated version (e.g., “on demand”), a capitalized entry (e.g.,“Software”) may be interchangeably used with its non-capitalized version(e.g., “software”), a plural term may be indicated with or without anapostrophe (e.g., PE's or PEs), and an italicized term (e.g., “N+1”) maybe interchangeably used with its non-italicized version (e.g., “N+1”).Such occasional interchangeable uses shall not be consideredinconsistent with each other.

Also, some embodiments may be described in terms of “means for”performing a task or set of tasks. It will be understood that a “meansfor” may be expressed herein in terms of a structure, such as aprocessor, a memory, an I/O device such as a camera, or combinationsthereof. Alternatively, the “means for” may include an algorithm that isdescriptive of a function or method step, while in yet other embodimentsthe “means for” is expressed in terms of a mathematical formula, prose,or as a flow chart or signal diagram.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

It is noted at the outset that the terms “coupled,” “connected”,“connecting,” “mechanically connected,” etc., are used interchangeablyherein to generally refer to the condition of being physicallyconnected. If any disclosures are incorporated herein by reference andsuch incorporated disclosures conflict in part and/or in whole with thepresent disclosure, then to the extent of conflict, and/or broaderdisclosure, and/or broader definition of terms, the present disclosurecontrols. If such incorporated disclosures conflict in part and/or inwhole with one another, then to the extent of conflict, the later-dateddisclosure controls.

The terminology used herein can imply direct or indirect, full orpartial, temporary or permanent, immediate or delayed, synchronous orasynchronous, action or inaction. For example, when an element isreferred to as being “on,” “connected” or “coupled” to another element,then the element can be directly on, connected or coupled to the otherelement and/or intervening elements may be present, including indirectand/or direct variants. In contrast, when an element is referred to asbeing “directly connected” or “directly coupled” to another element,there are no intervening elements present.

Although the terms first, second, etc. may be used herein to describevarious elements, components, regions, layers and/or sections, theseelements, components, regions, layers and/or sections should notnecessarily be limited by such terms. These terms are only used todistinguish one element, component, region, layer or section fromanother element, component, region, layer or section. Thus, a firstelement, component, region, layer or section discussed below could betermed a second element, component, region, layer or section withoutdeparting from the teachings of the present disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be necessarily limiting of thedisclosure. As used herein, the singular forms “a,” “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. The terms “comprises,” “includes” and/or“comprising,” “including” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

Example embodiments of the present disclosure are described herein withreference to illustrations of idealized embodiments (and intermediatestructures) of the present disclosure. As such, variations from theshapes of the illustrations as a result, for example, of manufacturingtechniques and/or tolerances, are to be expected. Thus, the exampleembodiments of the present disclosure should not be construed asnecessarily limited to the particular shapes of regions illustratedherein, but are to include deviations in shapes that result, forexample, from manufacturing.

Any and/or all elements, as disclosed herein, can be formed from a same,structurally continuous piece, such as being unitary, and/or beseparately manufactured and/or connected, such as being an assemblyand/or modules. Any and/or all elements, as disclosed herein, can bemanufactured via any manufacturing processes, whether additivemanufacturing, subtractive manufacturing and/or other any other types ofmanufacturing. For example, some manufacturing processes include threedimensional (3D) printing, laser cutting, computer numerical control(CNC) routing, milling, pressing, stamping, vacuum forming,hydroforming, injection molding, lithography and/or others.

Any and/or all elements, as disclosed herein, can include, whetherpartially and/or fully, a solid, including a metal, a mineral, aceramic, an amorphous solid, such as glass, a glass ceramic, an organicsolid, such as wood and/or a polymer, such as rubber, a compositematerial, a semiconductor, a nano-material, a biomaterial and/or anycombinations thereof. Any and/or all elements, as disclosed herein, caninclude, whether partially and/or fully, a coating, including aninformational coating, such as ink, an adhesive coating, a melt-adhesivecoating, such as vacuum seal and/or heat seal, a release coating, suchas tape liner, a low surface energy coating, an optical coating, such asfor tint, color, hue, saturation, tone, shade, transparency,translucency, non-transparency, luminescence, anti-reflection and/orholographic, a photo-sensitive coating, an electronic and/or thermalproperty coating, such as for passivity, insulation, resistance orconduction, a magnetic coating, a water-resistant and/or waterproofcoating, a scent coating and/or any combinations thereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this disclosure belongs. Theterms, such as those defined in commonly used dictionaries, should beinterpreted as having a meaning that is consistent with their meaning inthe context of the relevant art and should not be interpreted in anidealized and/or overly formal sense unless expressly so defined herein.

Furthermore, relative terms such as “below,” “lower,” “above,” and“upper” may be used herein to describe one element's relationship toanother element as illustrated in the accompanying drawings. Suchrelative terms are intended to encompass different orientations ofillustrated technologies in addition to the orientation depicted in theaccompanying drawings. For example, if a device in the accompanyingdrawings is turned over, then the elements described as being on the“lower” side of other elements would then be oriented on “upper” sidesof the other elements. Similarly, if the device in one of the figures isturned over, elements described as “below” or “beneath” other elementswould then be oriented “above” the other elements. Therefore, theexample terms “below” and “lower” can, therefore, encompass both anorientation of above and below.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. The descriptions are not intended to limit the scope of theinvention to the particular forms set forth herein. To the contrary, thepresent descriptions are intended to cover such alternatives,modifications, and equivalents as may be included within the spirit andscope of the invention as defined by the appended claims and otherwiseappreciated by one of ordinary skill in the art. Thus, the breadth andscope of a preferred embodiment should not be limited by any of theabove-described exemplary embodiments.

What is claimed is:
 1. A device, comprising: a torso connection membersecurable to a torso of a patient; a forearm support member that coupleswith at least a forearm of a patient, wherein the forearm support membercouples with the torso connection member so as to fix an elbow of thepatient proximate the torso, the forearm support member being pivotallycoupled to the torso connection member to allow for a dynamic anglebetween the forearm support member and a coronal plane of the patient,the forearm support member comprising a walled portion that cradles anelbow of the patient; a linkage extending from the torso connectionmember, the linkage comprising a pivoting connection to the forearmsupport member, the pivoting connection being located below and directlyunderneath the elbow of the patient; a dynamic tensioning assembly thatexternally rotates the forearm support member and selectively sets theangle so as to stretch a shoulder capsule affected with adhesivecapsulitis so as to reduce the adhesive capsulitis, the dynamictensioning assembly comprising: a dial coupled to a cable; anelastomeric or resilient strap coupled to a terminal end of the cable,the elastomeric or resilient strap extending through a retaining slotbehind the elbow and overlapping an outer surface of the forearm supportmember, the elastomeric or resilient strap being coupled to the outersurface of the forearm support member at an anchor point located betweena wrist of the patient and the elbow of the patient; and wherein thedynamic tensioning assembly exerts a dynamic force that can be resistedagainst by the patient to decrease the angle between the forearm supportmember and the coronal plane of the patient, such that during use thedynamic force being created by the patient turning the dial, which drawsthe cable into the dial and pulls on the elastomeric or resilient strap,the elastomeric or resilient strap exerting an outwardly directed forceon the forearm support member at the anchor point that results in theexternal rotation of the forearm support member, an increases thedynamic angle, and stretching of the shoulder capsule, the externalrotation causing the forearm of the patient to rotate away from thetorso while the elbow of the patient remains fixed; wherein theelastomeric or resilient strap is lengthened and the dynamic angle isdecreased when the patient internally rotates the forearm in a directionthat is opposite of the outwardly directed force, the elbow of thepatient remaining anchored as the forearm is internally or externallyrotated.
 2. The device according to claim 1, wherein the tensioning ofthe strap allows the patient to internally rotate or externally rotatethe forearm support member to exercise the shoulder capsule, the strapresisting the internal or external rotation of the forearm supportmember by the patient.
 3. The device according to claim 1, furthercomprising a resiliently biased coupling between the torso connectionmember and the forearm support member.
 4. The device according to claim1, wherein the torso connection member comprises: a contoured bodyportion that is configured to rest proximate an iliac crest and hip ofthe patient; and a belt that secures the contoured body portion to thetorso.
 5. The device according to claim 1, wherein the forearm supportmember comprises a proximal grip that receives a hand of the patient,the proximal grip comprising two grip handles.
 6. The device accordingto claim 5, wherein the proximal grip is slidably extendable toselectively vary a length of a forearm retaining portion of the forearmsupport member.